Comparison of Preoperative ABUS and MRI in Newly Diagnosed Breast Cancer Patients

Not Applicable

• Conditions: Breast Cancer
• Interventions: Device: ABUS

• Registration Number: NCT02488187
• Lead Sponsor: University of Kansas Medical Center

Brief Summary

Comparison of Preoperative Automated Breast Ultrasound (ABUS) and magnetic resonance imaging (MRI) in Newly Diagnosed Breast Cancer Patients.

Detailed Description

This is a prospective pilot study investigating the use of Automated Breast Ultrasound in the preoperative evaluation of newly diagnosed breast cancer patients. The Investigator intends to demonstrate that preoperative automated breast ultrasound (ABUS) will provide a relatively inexpensive and well-tolerated alternative to MRI for detection of occult breast cancer missed by mammography and hand-held ultrasound in women with newly diagnosed breast cancer. The research will take place at the University of Kansas Medical Center (KUMC). The research study will be open to newly diagnosed breast cancer patients who present to KUMC with a recommendation for preoperative MRI and who fit all inclusion criteria and have none of the exclusion criteria.

Study Timeline

• Study Start: 2013-04
• Study First Submitted: 2015-06-30
• Study First Submitted QC: 2015-06-30
• Study First Posted: 2015-07-02
• Status Verified: 2016-07
• Primary Completion: 2016-07
• Last Update Submitted: 2017-01-18
• Last Update Posted: 2017-01-19
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 115

Inclusion Criteria

• Women (age 18-100) undergoing preoperative evaluation at the University of Kansas Cancer Center (KUCC) for a new diagnosis of breast cancer
• Patients with a diagnosis of breast cancer by either core needle biopsy or excisional biopsy.
• Bilateral mammography and hand-held ultrasound (if clinically indicated) performed prior to the MRI and ABUS.
• If a breast MRI is advised and there is no contraindication to MRI, a breast MRI and ABUS will performed at KUCC (Study Arm 1).
• If a breast MRI is not performed, an ABUS exam without MRI will be performed (Study Arm 2).
• The MRI and ABUS exam must be obtained within 2 weeks of each other.

Exclusion Criteria

• Males
• Pregnant women
• Lactating women
• Patients < 18 and > 100 years of age
• Patients with breast implants

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ABUS vs MRI (ultrasound when indicated)	ABUS	To compare the overall sensitivity and specificity of ABUS versus MRI (and hand-held breast ultrasound when clinically indicated) for the ipsilateral and contralateral breast in newly diagnosed breast cancer patients.
ABUS vs mammography (ultrasound when indicated)	ABUS	To compare the sensitivity and specificity of ABUS versus mammography (and hand-held breast ultrasound when clinically indicated) for the ipsilateral and contralateral breast in newly diagnosed breast cancer patients when MRI is not performed.

Primary Outcome Measures

Name	Time	Method
Measure rate of detection of occult breast cancer by ABUS that was not detected by standard imaging	1 day	Rate of detection of occult breast cancer by ABUS, otherwise missed by standard imaging (MRI or mammogram with hand-held breast ultrasound as clinically indicated).

Trial Locations

Locations (1)

University of Kansas Cancer Center; 🇺🇸 Westwood, Kansas, United States